Blood Endothelium Progenitor Cells and Dendritic Cells as... | NCT00493597

Studies
Blood Endothelium Progenitor Cells and Dendritic Cells as Predictive Biomarkers of In-stent Restenosis

NCT00493597

Sponsor

University Hospital, Antwerp

Status

Completed

Last Update Posted

Nov 4, 2022Actual

Enrollment

124Actual

Phase

Not provided

Conditions

Atherosclerosis
Restenosis

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Oct 26, 2020Actual

Completion Date

Oct 26, 2020Actual

First Submitted Date

Jun 27, 2007

First Submission Date that Met QC Criteria

Jun 27, 2007

First Posted Date

Jun 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2022

Last Update Posted Date

Nov 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

clinically relevant in stent restenosis occurs in 5-10% of the non-diabetic patients treated with a coronary bare metal stent. Recent research has identified endothelial progenitor cells as well as dendritic cells as components of neointima. Numerical and functional evaluation of endothelial progenitor and dendritic cells at the time of coronary stent implantation is assessed and the relation with clinical and/or angiographic restenosis at 6 months post-stent implantation is evaluated.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age>18 years old
Scheduled for PCI
Candidate for CABG if necessary
Clinical evidence of ischemic heart disease and/or abnormal functional study
New native coronary artery lesion >50%-<100% stenosis
Lesion length<30 mm, treatment with a single bare metal stent planned
Reference diameter 2.5-3.5 mm
Informed consent explained, red, understood and signed by the patient

Exclusion Criteria:

Pregnancy, birth or lactation period <6 months ago
Women of childbearing age who do not intend to use accepted anticonceptive measures or who wish to get pregnant
Left ventricular ejection fraction <30%
Acute myocardial infarction (ST-elevation, Q-wave evolution or CK-MB >2x upper limit of normal)in the past month
Contra-indication to PCI
Diabetes mellitus
Planned drug eluting stent implantation
Total occlusion (TIMI 0 or 1)
Ostial localisation (<3.0 mm of the coronary ostium) of the lesion
Bifurcational lesion with side branch >2.0 mm or side branch which will be recanalised at occlusion due to PCI
Lesion in arterial or venous bypass or anastomosis with coronary
Angiographic contra-indication to IVUS
Severe renal insufficiency (creatinine clearance <30 mL/')
Severe hepatic insufficiency
Systemic inflammatory pathology of any kind
Uncorrected hyperthyreosis
Hematologic or other malignancy, prior radio- or chemotherapy
Severe peripheral artery disease (accesproblem via groin)
Use of corticosteroïds or immune suppression therapy
Contrastallergy
Life expectancy <1 year
Participation in other clinical study which has not ended yet

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Non-diabetic patients scheduled for PCI with a single bare metal stent in a significant de novo coronary lesion

Sampling Method

Non-Probability Sample

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases